Could a common heart drug stop diabetes-related heart failure?
NCT ID NCT03744975
First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tested whether the drug Entresto (LCZ 696) can improve how the kidneys and heart handle extra salt and fluid in people with type 2 diabetes. Some participants had early signs of heart stiffness (diastolic dysfunction) and others did not. The goal was to see if the drug could prevent progression to full-blown heart failure. The study involved 72 adults and measured changes in blood and urine markers after a saline infusion.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Entresto (LCZ 696, a neprilysin inhibitor)
- What this could lead to
- If successful, this could point toward a way to prevent heart failure in people with type 2 diabetes who have early signs of heart stiffness.
- What could go wrong
- This is a small, early-phase study (72 participants) that measures short-term body responses, not long-term outcomes. The drug may not prevent heart failure in real-world use.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
-
72 people
The number who actually took part.
- Started
-
May 2018
- Finished
-
Aug 2025
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 years and older
- Sex
-
Anyone
- Healthy volunteers
-
Accepted
You do not need to have the condition being studied to take part.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria * Type 2 diabetes mellitus * On at least one oral hypoglycemic agent, or glucagon-like peptide analogue or insulin, for at least 6 months * EF \> 50% without diastolic dysfunction or EF \> 50% with grade 2 or more diastolic dysfunction, without prior diagnosis, or signs and symptoms, of heart failure * Minimal distance of \>450 meters on a 6-minute walk. If the subject is not able to walk 450 meters due to pain in hips and/or knees, and not fatigue or shortness of breath, then they will still qualify for the protocol. Exclusion Criteria * HbA1C\> 9 % at enrollment * prior diagnosis, or signs and symptoms, of heart failure; * Currently taking a loop diuretic * myocardial infarction within 6 months of Visit 2 * unstable angina within 6 months of Visit 2 * significant (\> moderate) valvular stenosis, hypertrophic, restrictive or obstructive cardiomyopathy, constrictive pericarditis, primary pulmonary hypertension, or biopsy proven active myocarditis * severe congenital heart diseases * sustained ventricular tachycardia or ventricular fibrillation within 14 days of screening * second or third degree heart block without a permanent cardiac pacemaker * stroke within 3 months of screening, or other evidence of significantly compromised CNS perfusion * ALT \>2 times the upper limit of normal * serum sodium of \< 125 mEq/dL or \> 160 mEq/dL * serum potassium of \< 3.5 mEq/dL or \> 5.9 mEq/dL * hemoglobin \< 9 gm/dl * eGFR \< 30 ml/min (at screening) * other acute or chronic medical conditions or laboratory abnormality which may increase the risks associated with study participation or may interfere with interpretation of the data * received an investigational drug within 1 month prior to dosing; * patients with an allergy to iodine * female subject who is pregnant or breastfeeding * in the opinion of the investigator, is unlikely to comply with the study protocol or is unsuitable for any reason
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Mayo Clinic in Rochester
Rochester, Minnesota, 55905, United States
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